It is not uncommon for manufacturing companies in Florida and elsewhere to outsource some of their processes to increase production or for many other reasons. It remains the responsibility of the company owner to ensure that procedures at the third-party's manufacturing facility meet the high standards required by the Food and Drug Administration (FDA) and other regulators. If any issues of personal injury arise due to improper procedures followed at the subcontractor's premises, the manufacturing company may be held liable.
Sagent Pharmaceuticals, Inc. recently announced a recall of some of its atracurium besylate injections in various sizes and both single and multi-dose vials. The drug is used to relax skeletal muscles during surgery, and it also facilitates endotracheal intubation for mechanical ventilation. The voluntary recall follows observations by the FDA that the manufacturing process failed to adhere to required standards, by which sterile products should be handled in a manner that will not compromise sterility. It was also noted that GMP standards were not maintained.